RAC Practice Exam – Complete Guide for Regulatory Affairs Certification

The approval process for an allergen patch test typically falls under the jurisdiction of the Center for Biologics Evaluation and Research (CBER) because these tests often involve biological products, including allergens that may be derived from living organisms. CBER is responsible for ensuring the safety and effectiveness of biologics, which include vaccines, blood products, and allergenic extracts. An allergen patch test is used to determine sensitivity to specific allergens and often relies on biologically derived substances, making CBER the appropriate center for oversight of such products.

Other centers focus on different types of products: the Center for Drug Evaluation and Research (CDER) manages pharmaceuticals, the Center for Devices and Radiological Health (CDRH) oversees medical devices, and the FDA Office of Combination Products handles products that fall into more than one category or that combine different types of products. Since allergen patch tests are biologically based, CBER's expertise and regulatory framework align best with the requirements for approving such tests.